Test Request Distributor — Class II medical device recall Z-1548-2015
Terminated recall by Dako North America Inc., reported 2015-05-06, distributed nationwide. If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software
| Recall number | Z-1548-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2015-04-01 |
| Classified | 2015-04-29 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, DK, ES, FI, FR, GB, KR, NL, SE |
| Reason classes | labeling, software |
| Serial numbers | 1304008205, 1305006010, 1306001697, 1307000537, 1307006995, 1308004862, 1310010425, 1311001075, 1311004352, 1311004354, 1311004355, 1311007317, 1311007321, 1401000919, 1401001048, 1401003711, 1401003715, 1401005960, 1401005963, 1401010308, 1402002186, 1402005995, 1403005465, 1404004226, 1404006200 and 8 more |
Product
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.
Reason for recall
If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1548-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.